Cleared Traditional

AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER

K121275 · Convatec, Inc. · General & Plastic Surgery
Jul 2012
Decision
89d
Days
—
Risk

About This 510(k) Submission

K121275 is an FDA 510(k) clearance for the AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER, a Dressing, Wound, Drug, submitted by Convatec, Inc. (Skillman, US). The FDA issued a Cleared decision on July 25, 2012, 89 days after receiving the submission on April 27, 2012. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K121275 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2012
Decision Date July 25, 2012
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class —

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